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A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial.
Trials 2016; 17(1):119T

Abstract

BACKGROUND

Treatment guidelines recommend watchful waiting for children older than 2 years with acute otitis media (AOM) without perforation, unless they are at high risk of complications. The high prevalence of chronic suppurative otitis media (CSOM) in remote Aboriginal and Torres Strait Islander communities leads these children to be classified as high risk. Urban Aboriginal and Torres Strait Islander children are at lower risk of complications, but evidence to support the subsequent recommendation for watchful waiting in this population is lacking.

METHODS/DESIGN

This non-inferiority multi-centre randomised controlled trial will determine whether watchful waiting is non-inferior to immediate antibiotics for urban Aboriginal and Torres Strait Islander children with AOM without perforation. Children aged 2 - 16 years with AOM who are considered at low risk for complications will be recruited from six participating urban primary health care services across Australia. We will obtain informed consent from each participant or their guardian. The primary outcome is clinical resolution on day 7 (no pain, no fever of at least 38 °C, no bulging eardrum and no complications of AOM such as perforation or mastoiditis) as assessed by general practitioners or nurse practitioners. Participants and outcome assessors will not be blinded to treatment. With a sample size of 198 children in each arm, we have 80 % power to detect a non-inferiority margin of up to 10 % at a significance level of 5 %, assuming clinical improvement of at least 80 % in both groups. Allowing for a 20 % dropout rate, we aim to recruit 495 children. We will analyse both by intention-to-treat and per protocol. We will assess the cost- effectiveness of watchful waiting compared to immediate antibiotic prescription. We will also report on the implementation of the trial from the perspectives of parents/carers, health professionals and researchers.

DISCUSSION

The trial will provide evidence for the safety and effectiveness of watchful waiting for the management of AOM in Aboriginal and Torres Strait Islander children living in urban settings who are considered to be at low risk of complications.

TRIAL REGISTRATION

The trial is registered with Australia New Zealand Clinical Trials Registry (ACTRN12613001068752). Date of registration: 24 September 2013.

Authors+Show Affiliations

School of Medicine, Western Sydney University, Sydney, NSW, Australia. p.abbott@westernsydney.edu.au.University of Sydney, Sydney, NSW, Australia. hasantha.gunasekera@sydney.edu.au.Menzies School of Health Research, Darwin, NT, Australia. Amanda.Leach@menzies.edu.au.Discipline of General Practice, University of Queensland, Brisbane, QLD, Australia. Deborah.askew@health.qld.gov.au. Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care (Inala Indigenous Health Service), Queensland Health, Brisbane, QLD, Australia. Deborah.askew@health.qld.gov.au.School of Medicine, Western Sydney University, Sydney, NSW, Australia. r.walsh@westernsydney.edu.au.University of Newcastle, Newcastle, NSW, Australia. a.profkkong@hunterent.com.au.School of Medicine, Western Sydney University, Sydney, NSW, Australia. f.girosi@westernsydney.edu.au.Indigenous Studies Research Network, Queensland University of Technology, Brisbane, QLD, Australia. chelsea.bond@qut.edu.au.Menzies School of Health Research, Darwin, NT, Australia. Peter.Morris@menzies.edu.au.School of Medicine, Western Sydney University, Sydney, NSW, Australia. s.lujic@unsw.edu.au. Centre for Big Data Research in Health, University of NSW, Sydney, NSW, Australia. s.lujic@unsw.edu.au.School of Medicine, Western Sydney University, Sydney, NSW, Australia. w.hu@westernsydney.edu.au.Sydney Medical School Westmead, University of Sydney, Sydney, NSW, Australia. tim.usherwood@sydney.edu.au.Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care (Inala Indigenous Health Service), Queensland Health, Brisbane, QLD, Australia. Claudette.Tyson@health.qld.gov.au.Discipline of General Practice, University of Queensland, Brisbane, QLD, Australia. g.spurling@uq.edu.au. Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care (Inala Indigenous Health Service), Queensland Health, Brisbane, QLD, Australia. g.spurling@uq.edu.au.Awabakal Aboriginal Primary Health Care Centre, Newcastle, NSW, Australia. mdouglas@awabakal.org.Awabakal Aboriginal Primary Health Care Centre, Newcastle, NSW, Australia. KSchubert@awabakal.org.Winnunga Nimmityjah Aboriginal Health Service, Canberra, ACT, Australia. Shavaun.Chapman@winnunga.org.au.Winnunga Nimmityjah Aboriginal Health Service, Canberra, ACT, Australia. Nadeem.Siddiqui@winnunga.org.au.Winnunga Nimmityjah Aboriginal Health Service, Canberra, ACT, Australia. Reeion.Murray@winnunga.org.au.Aboriginal and Torres Strait Islander Community Health Services, Brisbane, QLD, Australia. Keitha.Rabbitt@atsichsbrisbane.org.au.Aboriginal and Torres Strait Islander Community Health Services, Brisbane, QLD, Australia. Bobby.Porykali@atsichsbrisbane.org.au.Tharawal Aboriginal Corporation, Sydney, NSW, Australia. Cheryl.Woodall@tacams.com.au.Tharawal Aboriginal Corporation, Sydney, NSW, Australia. tina.newman@tacams.com.au.School of Medicine, Western Sydney University, Sydney, NSW, Australia. j.reath@westernsydney.edu.au.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26941013

Citation

Abbott, Penelope, et al. "A Multi-centre Open-label Randomised Non-inferiority Trial Comparing Watchful Waiting to Antibiotic Treatment for Acute Otitis Media Without Perforation in Low-risk Urban Aboriginal and Torres Strait Islander Children (the WATCH Trial): Study Protocol for a Randomised Controlled Trial." Trials, vol. 17, no. 1, 2016, p. 119.
Abbott P, Gunasekera H, Leach AJ, et al. A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial. Trials. 2016;17(1):119.
Abbott, P., Gunasekera, H., Leach, A. J., Askew, D., Walsh, R., Kong, K., ... Reath, J. (2016). A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial. Trials, 17(1), p. 119. doi:10.1186/s13063-016-1247-y.
Abbott P, et al. A Multi-centre Open-label Randomised Non-inferiority Trial Comparing Watchful Waiting to Antibiotic Treatment for Acute Otitis Media Without Perforation in Low-risk Urban Aboriginal and Torres Strait Islander Children (the WATCH Trial): Study Protocol for a Randomised Controlled Trial. Trials. 2016 Mar 3;17(1):119. PubMed PMID: 26941013.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial. AU - Abbott,Penelope, AU - Gunasekera,Hasantha, AU - Leach,Amanda Jane, AU - Askew,Deborah, AU - Walsh,Robyn, AU - Kong,Kelvin, AU - Girosi,Federico, AU - Bond,Chelsea, AU - Morris,Peter, AU - Lujic,Sanja, AU - Hu,Wendy, AU - Usherwood,Tim, AU - Tyson,Sissy, AU - Spurling,Geoffrey, AU - Douglas,Markeeta, AU - Schubert,Kira, AU - Chapman,Shavaun, AU - Siddiqui,Nadeem, AU - Murray,Reeion, AU - Rabbitt,Keitha, AU - Porykali,Bobby, AU - Woodall,Cheryl, AU - Newman,Tina, AU - Reath,Jennifer, Y1 - 2016/03/03/ PY - 2015/12/12/received PY - 2016/02/20/accepted PY - 2016/3/5/entrez PY - 2016/3/5/pubmed PY - 2016/12/15/medline SP - 119 EP - 119 JF - Trials JO - Trials VL - 17 IS - 1 N2 - BACKGROUND: Treatment guidelines recommend watchful waiting for children older than 2 years with acute otitis media (AOM) without perforation, unless they are at high risk of complications. The high prevalence of chronic suppurative otitis media (CSOM) in remote Aboriginal and Torres Strait Islander communities leads these children to be classified as high risk. Urban Aboriginal and Torres Strait Islander children are at lower risk of complications, but evidence to support the subsequent recommendation for watchful waiting in this population is lacking. METHODS/DESIGN: This non-inferiority multi-centre randomised controlled trial will determine whether watchful waiting is non-inferior to immediate antibiotics for urban Aboriginal and Torres Strait Islander children with AOM without perforation. Children aged 2 - 16 years with AOM who are considered at low risk for complications will be recruited from six participating urban primary health care services across Australia. We will obtain informed consent from each participant or their guardian. The primary outcome is clinical resolution on day 7 (no pain, no fever of at least 38 °C, no bulging eardrum and no complications of AOM such as perforation or mastoiditis) as assessed by general practitioners or nurse practitioners. Participants and outcome assessors will not be blinded to treatment. With a sample size of 198 children in each arm, we have 80 % power to detect a non-inferiority margin of up to 10 % at a significance level of 5 %, assuming clinical improvement of at least 80 % in both groups. Allowing for a 20 % dropout rate, we aim to recruit 495 children. We will analyse both by intention-to-treat and per protocol. We will assess the cost- effectiveness of watchful waiting compared to immediate antibiotic prescription. We will also report on the implementation of the trial from the perspectives of parents/carers, health professionals and researchers. DISCUSSION: The trial will provide evidence for the safety and effectiveness of watchful waiting for the management of AOM in Aboriginal and Torres Strait Islander children living in urban settings who are considered to be at low risk of complications. TRIAL REGISTRATION: The trial is registered with Australia New Zealand Clinical Trials Registry (ACTRN12613001068752). Date of registration: 24 September 2013. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/26941013/A_multi_centre_open_label_randomised_non_inferiority_trial_comparing_watchful_waiting_to_antibiotic_treatment_for_acute_otitis_media_without_perforation_in_low_risk_urban_Aboriginal_and_Torres_Strait_Islander_children__the_WATCH_trial_:_study_protocol_for_a_randomised_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1247-y DB - PRIME DP - Unbound Medicine ER -